83558 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 

USPTO requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

September 21, 2022, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

Koselugo represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

Koselugo is 5,100 days. Of this time, 

4,889 days occurred during the testing 

phase of the regulatory review period, 

while 211 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: April 26, 2006. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on April 26, 2006. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: September 13, 2019. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

Koselugo (NDA 213756) was initially 

submitted on September 13, 2019. 

3. The date the application was 

approved: April 10, 2020. FDA has 

verified the applicant’s claim that NDA 

213756 was approved on April 10, 2020. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 927 days, 1,550 

days, or 5 years of patent term 

extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: November 27, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26324 Filed 11–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–2089] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Rezurock 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Rezurock and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by January 29, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

May 28, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 29, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–E–2089 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; REZUROCK.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 83559 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with § 10.20 (21 

CFR 10.20) and other applicable 

disclosure law. For more information 

about FDA’s posting of comments to 

public dockets, see 80 FR 56469, 

September 18, 2015, or access the 

information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product Rezurock 

(belumosudil mesylate). Rezurock is 

indicated for the treatment of adult and 

pediatric patients 12 years and older 

with chronic graft-versus-host disease 

after failure of at least two prior lines of 

systemic therapy. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

Rezurock (U.S. Patent No. 8,357,693) 

from Kadmon Pharmaceuticals, LLC 

(agent for Surface Logix, LLC), and the 

USPTO requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

September 13, 2022, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

Rezurock represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

Rezurock is 4,327 days. Of this time, 

4,037 days occurred during the testing 

phase of the regulatory review period, 

while 290 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: September 12, 

2009. The applicant claims January 8, 

2016, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was September 12, 

2009, which was 30 days after FDA 

receipt of an earlier IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: September 30, 2020. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

Rezurock (NDA 214783) was initially 

submitted on September 30, 2020. 

3. The date the application was 

approved: July 16, 2021. FDA has 

verified the applicant’s claim that NDA 

214783 was approved on July 16, 2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,154 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 


khammond on DSKJM1Z7X2PROD with NOTICES
83560 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 

Dated: November 24, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26358 Filed 11–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meetings of the Presidential Advisory 

Council on Combating AntibioticResistant Bacteria 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that a virtual meeting is scheduled to be 

held for the Presidential Advisory 

Council on Combating AntibioticResistant Bacteria (PACCARB). The 

meeting will be open to the public and 

will be streamed live on hhs.gov/live. A 

pre-registered public comment session 

will be held during the meeting. Preregistration is required for members of 

the public who wish to present their 

comments live during the virtual 

meeting. Individuals who wish to 

provide written public comment should 

send an email to CARB@hhs.gov that 

includes their written comments. 

Registration information is available on 

the website http://www.hhs.gov/paccarb 

and should be completed by December 

18, 2023 for the December 20, 2023 

virtual Public Meeting. Additional 

information about registering for the 

meeting and providing public comment 

can be obtained at http://www.hhs.gov/ 

paccarb on the Upcoming Meetings 

page. HHS is also giving notice of the 

appointment of 16 new PACCARB 

councilmembers that will be sworn-in 

in preparation of the December 20, 2023 

virtual public meeting. 

DATES: The meeting is scheduled to be 

held on December 20, 2023, from 9 a.m. 

to 4 p.m. ET (times are tentative and 

subject to change). The confirmed times 

and agenda items for the meeting will be 

posted on the website for the PACCARB 

at http://www.hhs.gov/paccarb when 

this information becomes available. Preregistration for attending the meeting is 

strongly suggested and should be 

completed no later than December 18, 

2023. 

ADDRESSES: The virtual meeting can be 

accessed through a live webcast on the 

day of the meeting. Additional 

instructions regarding attending this 

meeting virtually will be posted at least 

one week prior to the meeting at: http:// 

www.hhs.gov/paccarb. 

FOR FURTHER INFORMATION CONTACT: 

Jomana Musmar, M.S., Ph.D., 

Designated Federal Officer, Presidential 

Advisory Council on Combating 

Antibiotic-Resistant Bacteria, Office of 

the Assistant Secretary for Health, U.S. 

Department of Health and Human 

Services, 1101 Wootton Parkway, 

Rockville, MD 20852. Phone: 202–746– 

1512; Email: CARB@hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Presidential Advisory Council on 

Combating Antibiotic-Resistant Bacteria 

(PACCARB), established by Executive 

Order 13676, is continued by section 

505 of Public Law 116–22, the 

Pandemic and All-Hazards 

Preparedness and Advancing Innovation 

Act of 2019 (PAHPAIA). Activities and 

duties of the PACCARB are governed by 

the provisions of the Federal Advisory 

Committee Act (FACA), Public Law 92– 

463, as amended (5 U.S.C. app.), which 

sets forth standards for the formation 

and use of federal advisory committees. 

The PACCARB shall advise and 

provide information and 

recommendations to the Secretary of 

Health and Human Services (Secretary) 

regarding programs and policies 

intended to reduce or combat antibioticresistant bacteria that may present a 

public health threat and improve 

capabilities to prevent, diagnose, 

mitigate, or treat such resistance. The 

PACCARB shall function solely for 

advisory purposes. 

Such advice, information, and 

recommendations may be related to 

improving: the effectiveness of 

antibiotics; research and advanced 

research on, and the development of, 

improved and innovative methods for 

combating or reducing antibiotic 

resistance, including new treatments, 

rapid point-of-care diagnostics, 

alternatives to antibiotics, including 

alternatives to animal antibiotics, and 

antimicrobial stewardship activities; 

surveillance of antibiotic-resistant 

bacterial infections, including publicly 

available and up-to-date information on 

resistance to antibiotics; education for 

health care providers and the public 

with respect to up-to-date information 

on antibiotic resistance and ways to 

reduce or combat such resistance to 

antibiotics related to humans and 

animals; methods to prevent or reduce 

the transmission of antibiotic-resistant 

bacterial infections; including 

stewardship programs; and coordination 

with respect to international efforts in 

order to inform and advance the United 

States capabilities to combat antibiotic 

resistance. 

The Advisory Council is authorized to 

consist of at least 30 members, 

including the voting and non-voting 

members and the Chair and Vice Chair. 

The current composition of the 

Advisory Council consists of 15 voting 

members, including the Chair and Vice 

Chair, eight non-voting liaison 

representative members, and 12 nonvoting ex-officio members. In March of 

2023, the terms of 16 councilmembers 

ended, and an announcement was 

published August 1, 2022 and closed on 

September 19, 2022 to solicit 

nominations to fill the open PACCARB 

positions, nine of which were in the 

voting member category, including the 

Chair and Vice-Chair positions, while 

the remaining seven were in the nonvoting liaison member category. These 

positions have been filled and the new 

PACCARB members will be sworn-in in 

preparation for the December 20, 2023, 

virtual public meeting. Newly 

appointed voting members were 

selected to serve four-year terms, and 

non-voting liaison members were 

appointed to serve for two-year terms. 

The full roster of councilmembers, 

including the 16 new members, can be 

found on the Membership page at http:// 

www.hhs.gov/paccarb. 

The December 20, 2023, virtual public 

meeting will be dedicated to current 

global U.S. federal efforts to combat 

antimicrobial resistance in response to a 

task from the Secretary given to the 

PACCARB in 2023. The signed task 

letter from the Secretary can be found at 

http://www.hhs.gov/paccarb. The 

meeting agenda will be posted on the 

PACCARB website at http://

www.hhs.gov/paccarb when it has been 

finalized. All agenda items and times 

are tentative and subject to change. 

Instructions regarding attending the 

meeting virtually will be posted at least 

one week prior to the meeting at: http:// 

www.hhs.gov/paccarb. 

Members of the public will have the 

opportunity to provide comments 

during the December meeting by preregistering online at http://

www.hhs.gov/paccarb. Pre-registration 

is required for participation in this 

session with limited spots available. 

Written public comments can also be 

emailed to CARB@hhs.gov by midnight 

December 18, 2023 and should be 

limited to no more than one page. All 

public comments received prior to 

December 18, 2023, will be provided to 

the PACCARB members. Additionally, 

companies and/or organizations 

involved in combating antibiotic 

resistance have an opportunity to 

present their work to members of the 


khammond on DSKJM1Z7X2PROD with NOTICES